Gardasil was approved by the FDA in June 2006 as a vaccine against certain strains of human papillomavirus (HPV). HPV is a real menace. A sexually transmitted disease, HPV has infected around 20 million people in the United States to date, with more than six million new cases occurring annually. The virus can cause a range of health problems from genital warts to cervical cancer.

There are over 100 different types of HPV: About 60 cause common skin warts (plantar, hand) and around 40 types affect the genital tissues and are sexually transmitted. Only a few of the genital types are considered high risk and can cause cancer.

Sexually transmitted strains of HPV are passed through direct genital contact. It cannot be transmitted by kissing or exposure to bodily fluids. But it is highly contagious. If you are sexually active, the odds of getting infected are very high. In one study, more than 50% of college women contracted an HPV infection within four years of the onset of sexual intercourse.

Most of the time, the immune system clears the virus from the body without any treatment. Unfortunately, each year several thousand infected women don’t clear the virus completely and develop cervical cancer. The Gardasil vaccine is reported to be nearly 100% effective in blocking four of the high risk strains of HPV that account for 70% of cervical cancer cases. It protects against two types of HPV that cause 90% of all genital warts and two types of HPV that cause 70% of all cervical cancer. Therefore, vaccinated women would still need to have regular Pap tests to rule out cervical cancer from other HPV strains.

Gardasil is approved for females ages 9-26 years old, based on clinical trials of over 25,000 patients. Only 4% or so of trial participants were pre-teens, so less information is available regarding the effectiveness and duration of the vaccine effect on young girls. Also, the vaccine hasn’t been around long enough to know exactly how long immunity will last; studies show the vaccine lasts for at least five years. Due to this uncertainty, some pediatricians are concerned that immunity may be waning at the time a young woman becomes sexually active. Therefore, some recommend waiting until the age of 11 or 12 before immunization.

While Gardasil may offer protection for women older than 26, the vaccine has not yet been approved for use in this age group. One reason may be that older sexually active women may have already acquired one (or all) of the four HPV types the vaccine protects against, thereby reducing its effectiveness. However, tests are now being done on the drug’s efficacy, safety and immune response in women ages 26-45. It is possible that even if a woman has been exposed to one of the four HPV types, the vaccine could prevent infection from subsequent exposure.

Gardasil has obtained wide-spread endorsement from groups such as the American Academy of Pediatrics, the American Academy of Family Physicians, and the Centers for Disease Control. All have placed Gardasil on their 2007 recommended immunization schedules. Reaching pre-teen girls before their first sexual experiences helps to assure that they are protected prior to HPV exposure. Once sexually active, they are at high risk of contracting the infection. Condoms offer incomplete protection because they do not cover all skin areas which may harbor the virus.

While acknowledging the vaccine as a tremendous breakthrough in protecting women from HPV-related diseases, many doctors also recognize the need for case by case consultations with each family to determine if Gardasil is the right choice.

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